Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation

• Conditions: Allergic Contact Dermatitis

• Registration Number: NCT00445029
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The current knowledge of the pathophysiology of allergic contact dermatitis is based on the murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the response by limiting the expansion of CD8+ T cells. The goal of this study is to characterize the pathophysiology of contact dermatitis, with patients allergic to para-phenylenediamine (PPD).

We suppose that the CD8+ T cells are the effectors of the allergic contact dermatitis, although the regulator cells belong to the LT CD4+ population. We will test our hypothesis on blood samples, and cutaneous biopsies of patients allergic to PPD.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-03
• Last Update Posted: 2007-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

For both groups:

• Patients aged from 18 to 65 years old.

• Both genders eligible for study.

• Female participants must use a contraceptive method.

• Feasibility of patch testing.

• Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.

• Patients must be registered in a social security system or with a health insurance coverage

   First group: allergic patients

• Patients with allergic contact dermatitis to para-phenylenediamine (PPD) based on a history of PPD contact dermatitis and positive PPD patch tests.

   Second group : healthy volunteers

• No history of PPD allergic contact dermatitis, with a negative PPD patch test.

Exclusion Criteria

• Pregnant or lactating women.
• Evolutive skin disease on the testing zone (lower back).
• Patients with a clinically significant disease (chronic, recurrent or active).
• Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid treatment the week before the patch testing.
• Local or systemic drug use which interacts with the outcome measures.
• Exposure to sun or UV radiations, 15 days before the patch testing.
• Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
• Patients subject to a protection measure.
• Patients in a critical medical situation.
• Patients with a personal situation judged by the investigator as unlikely to be compatible with optimal participation in the study, or which could constitute a risk for the patient.
• Linguistic barrier or psychological profile preventing the patient from signing the consent form.
• Patient still in an exclusion period following the participation in another clinical trial.
• Patients having earned more than 4500€ in indemnities for participation in clinical trials during the previous 12 months, including this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Jean-François Nicolas; 🇫🇷 Lyon, France